RATIONALE: Bimatoprost ophthalmic solution may help increase eyebrow and eyelash growth in patients who have undergone chemotherapy.

PURPOSE: This randomized clinical trial is studying how wells bimatoprost ophthalmic solution works in increasing eyebrow and eyelash growth in patients who have undergone chemotherapy for breast cancer and in healthy participants.

Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:

Measuring regrowth of eyebrows and eyelashes by Bimatoprost Opthalmic solution [ Time Frame: every 30 days for 4 months ] [ Designated as safety issue: No ]

Efficacy of Bimatoprost Opthalmic solution in expediting regrowth of eyebrows and eyelashes in patients who have undergone chemotherapy for breast cancer and in increasing eyebrow growth in healthy participants with no known underlying disease as assessed by two physicians and an aesthetics expert on a scale of 0-4.

Secondary Outcome Measures:

Effectiveness of Bimatoprost Ophthalmic Solution as assessed by patient self-report on a scale of 0-4. [ Time Frame: every 30 days for 4 months ] [ Designated as safety issue: No ]

Psychological impact as assessed at baseline and at 6 months by patient-completed questionnaires [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Patients apply topical bimatoprost ophthalmic solution to base of upper eyelid margins OR to eyebrow region once daily for 4 months in the absence of unacceptable toxicity.

Drug: bimatoprost ophthalmic solution

Applied topically

Placebo Comparator: Arm II

Patients apply topical placebo solution to base of upper eyelid margins OR to eyebrow region once daily for 4 months in the absence of unacceptable toxicity.

Drug: placebo

Applied topically

Detailed Description:

OBJECTIVES:

Primary

To assess the effectiveness of bimatoprost ophthalmic solution in expediting regrowth of eyebrows and eyelashes in patients who have undergone chemotherapy for breast cancer and in increasing eyebrow growth in healthy participants with no known underlying disease as assessed by two physicians and an aesthetics expert on a scale of 0-4.

Secondary

To assess the effectiveness of this treatment as assessed by patient self-report on a scale of 0-4.

To assess the psychological impact of this treatment as assessed by patient-completed questionnaires.

OUTLINE: Patients are randomized to 1 of 2 intervention arms.

Arm I: Patients apply topical bimatoprost ophthalmic solution to base of upper eyelid margins OR to eyebrow region once daily for 4 months in the absence of unacceptable toxicity.

Arm II: Patients apply topical placebo solution to base of upper eyelid margins OR to eyebrow region once daily for 4 months in the absence of unacceptable toxicity.

Patients complete questionnaires at baseline and monthly for 5 months about changes in eyebrows/eyelashes, side effects of treatment, and the psychological impact of treatment. Photographs of eyebrows or eyelashes and surrounding skin are taken at baseline and monthly for 5 months and reviewed by a physician and aesthetics expert.

After completion of study treatment, patients are followed up at 1 month.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Meets 1 of the following criteria:

Diagnosis of breast cancer (group 1)

Completed chemotherapy within the past month that has resulted in eyebrow alopecia or eyelash hypotrichosis

Eyebrow score of 0-2 or eyelash score of 0-2 on the study's qualitative eyebrow or eyelash growth chart

Has no known underlying disease (group 2)

Desires thicker, fuller, or more numerous eyebrows

Exclusion criteria

pregnant

does not Speak a language adequately covered by study translator services

cognitive impairment

history of trauma or burn to the eyebrow region, alopecia areata, or trichotillomania

known diagnoses possibly underlying or contributing to the state of the eyebrows including, but not limited to, telogen effluvium or anagen effluvium (group 2)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999557